Preeclampsia is one of the most common complications of pregnancy and is characterized by high blood pressure and protein in the urine. This can cause problems in the second half of pregnancy for both the mother and fetus. This study of preeclampsia consists of two parts: 1) a randomized, placebo controlled, multicenter clinical trial of 10,000 low-risk nulliparous women between 9 and 16 weeks gestation and 2) an observational, cohort study of 4,000 patients between 9 and 12 weeks gestation who are also enrolled in the trial.

Subjects in both parts will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. The purpose of the randomized, clinical trial is to find out if high doses of vitamin C and E will reduce the risk of preeclampsia and other problems associated with the disease. The study will also evaluate the safety of antioxidant therapy for mother and infant. Patients will be seen monthly to receive their supply of study drug, to have weight and blood pressure recorded, to have urine protein measured, and to assess any side effects. At two visits, blood and urine will be collected.

The observational, cohort study will prospectively measure potential biochemical and biophysical markers that might predict preeclampsia. These patients will have additional procedures including uterine artery Doppler and blood drawn for a complete blood count (CBC).

Preeclampsia is the leading cause of maternal morbidity, as well as perinatal morbidity and mortality. Once the diagnosis has been established, therapy other than delivery has not been successful except to prolong pregnancy minimally (at some risk to mother and infant). Prevention efforts to reduce or eliminate preeclampsia are directed at the pathophysiology of the disorder prior to clinically evident preeclampsia and before irreversible changes have occurred.

This double-masked, placebo-controlled trial of 10,000 subjects is designed to evaluate the effects of antioxidant therapy in preventing serious complications associated with pregnancy-related hypertension in low risk, nulliparous women who begin treatment at 9-16 weeks gestation. The hypothesis being tested is that antioxidant therapy initiated prior to 16 weeks gestation will reduce the frequency of serious maternal and infant complications associated with pregnancy-related hypertension.

After randomization, subjects will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. They will be seen for monthly pill counts and to assess side effects, weight, blood pressure, and urine for protein. Blood and urine are collected at 24 and 32 weeks' gestation.

An Observational Cohort Study to Predict Preeclampsia:

A prospective, cohort study has been designed to complement the randomized, controlled, trial (RCT) and will test various biochemical and biophysical markers for ability to predict preeclampsia in 4,000 of the women who are enrolled in the RCT and are between 9 and 12 weeks gestation. These subjects will have additional procedures including a CBC and uterine artery Doppler.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135707

Locations

United States, Alabama

University of Alabama - Birmingham

Birmingham, Alabama, United States, 35233

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Michigan

Wayne State University

Detroit, Michigan, United States, 48201

United States, New York

Columbia University

New York, New York, United States, 10032

United States, North Carolina

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Case Western University

Cleveland, Ohio, United States, 44109

Ohio State University

Columbus, Ohio, United States, 43210

United States, Oregon

Oregon Health and Sciences University

Portland, Oregon, United States, 97239

United States, Pennsylvania

Drexel University

Philadelphia, Pennsylvania, United States, 19107

University of Pittsburgh Magee Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

United States, Rhode Island

Brown University

Providence, Rhode Island, United States, 02905

United States, Texas

University of Texas - Southwest

Dallas, Texas, United States, 75235

University of Texas Medical Branch

Galveston, Texas, United States, 77555

University of Texas - Houston

Houston, Texas, United States, 77030

United States, Utah

University of Utah Medical Center

Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Director:

Catherine Spong, MD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)